Kornimate/medical-research-clean huggingface dataset:
luteal phase progesterone in iui and gonadotropin cycles

Conditions: Infertility

Summary: this is a study of patients undergoing controlled ovarian hyperstimulation (coh) with gonadotropins and intrauterine insemination (iui) at a fertility clinic. infertility is a common problem, and a popular method of therapy is to inject sperm through the cervix and into the uterus, a procedure known as iui. in conjunction with iui, injectable medications (gonadotropins) are used to stimulate the ovaries to produce more than one egg per cycle in a process called coh. vaginal progesterone is used for luteal support in in vitro fertilization therapy and has been proven to effect pregnancy rates. however, the role of progesterone in coh is still unclear. in this study, the investigators want to examine the effect of giving vaginal progesterone after coh with iui on pregnancy rates. the investigators want to study if luteal vaginal progesterone results in a higher pregnancy rate compared to no progesterone therapy in coh with iui. at present, fertility centres vary in the use of progesterone after insemination, most likely due to the lack of studies on this subject. at the fertility clinic all patients undergoing coh with injectable medications and iui, regardless of whether they are in the study, have a baseline transvaginal ultrasound and blood tests. patients start the injectable medications for coh until the ovarian follicles are large enough, then a medication to release the eggs is given. the iui is done approximately 36 hours later. the day after the iui, study patients will be given vaginal progesterone while the control patients will receive no progesterone. all patients will be followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.


Eligibility criteria:
inclusion criteria: * couples with infertility * confirmed bilateral tubal patency * more than 10 million motile sperm available for iui exclusion criteria: * subjects declining enrollment * allergies to prescribed vaginal progesterone * subjects less than 21 years old or over 43 years old

Keywords: controlled ovarian hyperstimulation gonadotropins intrauterine insemination infertility luteal progesterone
air optix® night and day® aqua continuous wear

Conditions: Refractive Errors

Summary: the purpose of this retrospective, post-market clinical follow-up (pmcf) study is to assess the long term performance and safety of air optix® night and day® aqua (aonda) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

this is a non-interventional/observational study designed as a retrospective chart review. study sites will identify charts within their existing databases in a fair and consistent manner. subjects/charts meeting the eligibility criteria will be enrolled in the study. the study is designed with one period. the duration of the period includes the baseline visit and the year 3 visit as follows: * the baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for aonda or purevision 2 (pv2) was released. * the year 3 visit is defined as a visit which occurred 3 years (-2/+8 months) since baseline during which period the subject was wearing aonda contact lenses or pv2 contact lenses and a contact lens examination was performed. the data collection period is defined as any approximately 3-year timeframe since and including 2009.

Eligibility criteria:
key inclusion criteria: * manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline * best corrected visual acuity of 20/25 or better in each eye at baseline * at the time of year 3 visit, subject was prescribed and wearing aonda or pv2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years * baseline visit and year 3 visit charts available key exclusion criteria: * any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline * the use of systemic or ocular medications contraindicating regular contact lens wear at baseline * history of refractive surgery or irregular cornea * slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline

Keywords: contact lenses overnight wear
underwater galvanic stimulation by 4-cell bath on lymphedema.

Conditions: Lymphedema

Summary: sixty female patients with lymphedema post mastectomy, aged 30-55 years, will be selected from minia oncology institute. the participants will be randomly distributed into two equal groups: 1. group a (cdt + underwater galvanic stimulation group): this group includes 30 patients who will receive underwater galvanic stimulation by 4-cell bath with cdt for 2 months (3times/week) in addition to their medical treatment. 2. group b (cdt group): this group includes 30 patients who will receive only cdt for 2 months (3times/week) in addition to their medical treatment.


Eligibility criteria:
inclusion criteria: * ▪ female patients with lymphedema post mastectomy * aged 30-55 years * no history of cardiac or renal disease * no contraindications to electrotherapy * all patients enrolled to the study will have their informed consent. exclusion criteria: * ▪ cardiac diseases. * patients with active cancer * patients with pacemakers or other implantable devices * patients with a history of seizures or epilepsy

Keywords: mastectomy
efficacy of a phone-based relapse prevention for anorexia nervosa after a first hospitalization

Conditions: Anorexia Nervosa

Summary: anorexia nervosa (an) is a highly challenging disease which consequences are serious. relapse rate is estimated between 38 and 41% during the year following hospitalization. the efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. however, no study has ever used phone contact as a relapse prevention intervention tool in an. objective: to evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for an, by comparison to standard medical follow-up. secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to an, rate of usual follow-up visit, and medico-economic impact. method: prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of an. patients randomized in eatline group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. patients in control group will benefit from usual follow-up. expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of an.


Eligibility criteria:
inclusion criteria: * subject over 15 years of age * diagnosis of an (restrictive and/or purgative) according to dsm-5 criteria * included after a first inpatient hospitalization in specialized care * providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority ) * with medical insurance * can be reached by telephone exclusion criteria: * uncompensated psychiatric pathology * refusal to participate in the study * the inability to consent to care (patient or his/her legal representative) * pregnancy * major incapable subject or under guardianship or judicial protection * homelessness * no mastery of reading and writing
text 2 connect- texting intervention for mental health treatment utilization

Conditions: Depression; Suicidal Ideation

Summary: text2connect (t2c) proposes to test a text-based intervention designed to improve engagement with mental health treatment.

to enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated tm intervention, "text to connect" (t2c), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth. assignment of interventions: the study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive t2c, and 1/3 to receive pe. blocks will balance the groups on site (ccp versus star/cabs). a 2:1 randomization scheme will randomize 50 youth to either receive t2c (n=30) or a link to brief psychoeducational videos about mental health (pe; n=20). all participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. youth randomized to receive pe will receive a text message with the link to the webpage with the psychoeducational videos. youth randomized to receive t2c will be onboarded and initiate the tm intervention that sends automated prompts at minimum monthly through month 4. hypothesis: aim 1. to examine the feasibility of t2c for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). youth randomized to receive t2c will: hypothesis 1a. engage with t2c at high rates (\>70% response rate to sms prompts). hypothesis 1b. report high levels of satisfaction (\>70% satisfaction) and usability with t2c. aim 2. to examine the impact of t2c versus pe on mental health self-efficacy, symptoms and functioning, and treatment engagement. over 4 months, youth who receive t2c, as compared with youth who receive pe, will report: hypothesis 2a (primary). greater mental health self-efficacy hypothesis 2b (secondary). lower symptom severity and greater psychosocial functioning hypothesis 2c (secondary). higher rates of follow-through with mental health services

Eligibility criteria:
inclusion criteria: * participant engaged in treatment at cc waterdam, star or cabs clinic * participants have a current psychiatric diagnosis documented in their electronic medical record and/or be in receipt of mental health services within 3 months per self-/ parent- or clinician- report * at least 18 years of age * recently graduated high school * planning to attend college or higher education program within 6 weeks * own a text-capable phone * be willing and able to provide informed consent exclusion criteria: * participants will be excluded if they have conditions that might impair their ability to effectively engage in text2connect * under the age of 18yo * non-english speakers

Keywords: depression suicidal ideation treatment mental health text message intervention
incidence of body dysmorphic disorder (bdd) in a population of patients undergoing orthognathic surgery

Conditions: Orthognathic Surgical Procedures; Psychiatric Disorders; Prognathism

Summary: assessment of the incidence of body dismorphic disorder in a population candidated to orthognathic surgery

assessment of the incidence of body dismorphic disorder in a population candidated to orthognathic surgery by using 3 validated questionnaires

Eligibility criteria:
inclusion criteria: * patients who are candidates for orthognathic surgery * age: 18 to 50 years; * informed consent exclusion criteria: * - patients diagnosed with another psychiatric pathology * patients affected by syndromes involving the cervical-facial district * patients affected by clefts * patients affected by osas and candidates for orthognathic surgery for this indication * patients affected by connective tissue disorders (e.g. ehler-danlos, scleroderma, etc.) * patients candidates for orthognathic surgery due to facial trauma

Keywords: orthognatic surgery body dismorphic disorder prognathism aesthetic surgery
adipocytokines, gestational diabetes mellitus and lipid metabolism

Conditions: Gestational Diabetes Mellitus

Summary: apelin, visfatin, omentin and resistin are adipocytokines derived from human adipose tissue as well as placental tissue and have been shown to be potential mediators of insulin resistance. in each pregnancy, a physiological insulin resistance syndrome occurs to ensure that the fetus is sufficiently supplied with glucose. due to their impact on glucose transport mechanisms adipocytokines play an important role for the development of insulin resistance. gestational diabetes mellitus (gdm) is one of the most common pregnancy - associated diseases with a prevalence of 5-10% of all pregnancies and its prevalence is increasing. it is associated with severe hazards to both mother and fetus such as macrosomia, plexus palsy, premature delivery and intrauterine death. furthermore, up to 50% of women with gdm develop type 2 diabetes mellitus (dm2) within the following ten years after pregnancy. gdm seems to be a potent risk factor for the development of dm2 in later life by sharing a number of epidemiological, physiological and genetic characteristics with dm2. therefore, alterations in adipocytokine levels in women with gdm, if present, may resemble those observed with dm2. furthermore, the exact pathogenesis of gdm is not completely understood, however, increased insulin resistance is a well demonstrated mechanism. adipocytokines are known to alter insulin resistance through several mechanisms described in the literature. the investigators therefore expect a possible relationship between the above described adipocytokines and gestational diabetes mellitus. results of the hapo-study have shown a significant association between fetal outcome and mean blood glucose levels in women suffering from gdm. the hapo study group supposed a possible relationship between gdm and fetal insulin levels and used c-peptide to quantify fetal hyperinsulinemia. a recent study suggests that not only hyperglycemia but also altered maternal lipid metabolism may constitute a risk factor for macrosomia in gdm. in summary, the investigators aim to illuminate a possible association between the adipocytokines apelin, omentin, resistin and visfatin, lipid metabolism and gestational diabetes mellitus.


Eligibility criteria:
inclusion criteria: * age above 18 years * informed consent * diagnosed gestational diabetes mellitus exclusion criteria: * preexisting diabetes mellitus * any kind of immunodeficiency * hiv, hcv, hbv * immunomodulating drugs (if-gamma, etc.) * cancer, chronic diseases

Keywords: adipocytokines
hope-epilepsy trial

Conditions: Epilepsy

Summary: this a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .


Eligibility criteria:
inclusion criteria: * patients with active epilepsy exclusion criteria: * pregnant women or breastfeeding

Keywords: epilepsy omega 3 fatty acids
the effect of touch on pain and anxiety during the bone marrow biopsy procedure

Conditions: Pain, Acute; Anxiety

Summary: this study is analyzing the benefit of untrained touch provided during a bone marrow biopsy procedure as compared to performing the procedure without providing it.

two protocol-identified licensed nursing aides (lna) will provide an unstructured simple touch intervention that requires no special training other than being oriented to "rub patient's feet" during the procedure. data will be collected through patient-reported outcomes to determine if "untrained" touch has therapeutic results in managing a patient's pain and anxiety during a bone marrow biopsy procedure.

Eligibility criteria:
inclusion criteria: 1. patients from norris cotton cancer center who have been scheduled for a bone marrow biopsy at the outpatient surgical center at dartmouth-hitchcock medical center. 2. subjects must be able to read and write in english to provide informed consent and fill out the questionnaires. exclusion criteria: 1. patients who do not wish to have their feet and lower legs touched during the procedure 2. open sores on their feet or lower legs.
endoscopic ultrasound (eus) guided-celiac plexus neurolysis (cpn) in unresectable pancreatic cancer

Conditions: Pain; Pancreatic Cancer

Summary: the purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (cpn) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.

the specific primary aim of this study is to evaluate the efficacy of eus-cpn + analgesic therapy (group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (group 2). the hypothesis will be tested by comparing the changes in reported pain severity between those who receive eus-cpn in addition to analgesic therapy as compared to analgesic therapy alone. the secondary aims of this study are to evaluate the efficacy of eus-cpn + analgesic therapy in improvement of quality of life (qol) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between group 1 when compared to group 2, and compare the referral for rescue block during the course of the study between group 1 and group 2

Eligibility criteria:
inclusion criteria: 1. male or female 2. age ≥19 yrs old 3. abdominal pain typical for pancreatic cancer ≥3/10 4. abdominal ct radiologically consistent with the diagnosis of pancreatic cancer 5. pancreatic cancer confirmed by fna during eus 6. inoperability of pancreatic cancer as determined during eus or prior ct exclusion criteria: 1. age \< 19 yrs old 2. unable to safely undergo eus for any reason 3. coagulopathy (prolongation of prothrombin time \> 18 sec, thrombocytopenia \<80,000 platelets/ml) 4. previous cpn or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy 5. another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder 6. potential patient noncompliance (refusing to follow schedule of events) 7. active alcohol or other drug use or significant psychiatric illness 8. pregnant or breastfeeding 9. unable to consent 10. non-english speaking

Keywords: ultrasound guided celiac plexus neurolysis cpn pancreatic cancer pain management
personalized prediction of persistent postsurgical pain

Conditions: Pain, Postoperative

Summary: p5 is planned as a prospective observational study, collecting evidence-based perioperative data on patient history and demographics, physical function, cognitive measures, psychological, and biological markers associated with increased pain susceptibility, and psychophysical measures of pain processing. the study will use daily ecologic momentary assessment (ema) of physical and emotional parameters, and collect data on perioperative events. follow up will occur 3 months and 6 months postoperatively.


Eligibility criteria:
inclusion criteria: * adults age 18-75 who are candidates for major surgery (expected surgery duration \>1 hour, and expected overnight admission to the hospital) * access to a smartphone exclusion criteria: * participants who do not speak english
the effects of provent® on obstructive sleep apnea during continuous positive airway pressure therapy withdrawal

Conditions: Obstructive Sleep Apnea

Summary: randomised, placebo-controlled trial of continuous positive airway pressure therapy (cpap) versus provent® and placebo-provent® to define the effects of provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.

randomised, placebo-controlled trial of provent® versus placebo-provent® versus continuous positive airway pressure therapy (cpap) to define the effects of provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk in patients with obstructive sleep apnea. patients successfully treated with cpap will be randomised to one of three arms for a duration of 2 weeks: 1. withdraw cpap and use provent® 2. withdraw cpap and use placebo-provent® 3. continue treatment with cpap

Eligibility criteria:
inclusion criteria: 1. objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (odi, \>4% dips) of between 10 and 50/h and an ess of \>10 (these thresholds will exclude subjects with borderline and very severe forms of osa in whom there may be a disproportionate treatment effect). 2. currently \>10/h oxygen desaturations (\>4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without cpap. 3. treated with ncpap for more than 12 months, minimum compliance 4h per night. 4. current ess \< 10. 5. written informed consent. exclusion criteria: 1. previous ventilatory failure (awake resting arterial oxygen saturation \ 6kpa). 2. unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (\>180/110mmhg). 3. previously diagnosed with cheyne-stokes breathing. 4. current professional driver. 5. any sleep related accident. 6. age \ 75 years at trial entry. 7. history of chronic nasal obstruction. 8. mental or physical disability precluding informed consent or compliance with the protocol . 9. non-feasible trial follow-up (for example, distance from follow-up centre, physical inability).
neurocognitive correlates of behavioral treatment for childhood tic disorders

Conditions: Tic Disorder

Summary: the study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (ctd) and to compare and contrast hypothesized mechanisms related to increased tic control associated with habit reversal training, a behavioral treatment that been previously shown to be effective in treating ctd. we also seek to better understand the relationship between fmri and quantitative eeg in relevant brain circuits with the hope of establishing eeg as a valid and cost-effective marker of treatment responsiveness. a total of 25 subjects will be randomized to 10 weeks of habit reversal training (hrt), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. treatment responders will be re-assessed at three months. waitlist nonresponders will be provided with 10 weeks of hrt. study assessments, including a neurocognitive battery and quantitative eeg will be administered at baseline, wk 5, wk 10, and 3-month follow-up. neuroimaging (fmri) will be conducted at baseline and wk 10.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnostic criteria for ctd (cmvt or ts) * clinical global impressions - severity score \> 3 (moderately ill or worse) * ygtss total score \> 14 (or total score \> 10 if ctd with motor tics only) * unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation * child is fluent english speaker * parental informed consent and child informed assent. exclusion criteria: * total ygtss score\>35 (cases above this threshold otherwise eligible will be reviewed by clinical caseness panel for potential study participation) * iq \< 80 on the wechsler abbreviated scale of intelligence (wasi) * problematic substance use or dsm-iv conduct disorder in past 3 months * lifetime dsm-iv diagnosis of pdd, mania, or psychotic disorder * any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study * previous treatment with four or more sessions of hrt for tics * contraindication to fmri scan

Keywords: tourette syndrome chronic tic disorder tics behavior therapy habit reversal training child adolescent neuroimaging